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Solifenacin succinate 10 mg Tablet, Film Coated, 90-count — NDC 72303-0832-02 package photo

Solifenacin succinate 10 mg Tablet, Film Coated, 90-count

by HEC Pharm USA Inc. · 90 TABLET, FILM COATED in 1 BOTTLE (72303-0832-2)
NDC 72303-0832-02
🏷️ FDA NDC (as labeled) 72303-0832-2 billing pads the package segment with a zero
This package
Contains90-count Pack sizes2 compare ↓
Also comes in: 30 tablets 72303-0832-01
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Solifenacin Succinate (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0333-2025
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0317-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 72303-0832-2
Product NDC 72303-0832
11-digit billing NDC 72303083202
RxCUI 477367, 477372
UNII KKA5DLD701
UPC 0372303083227, 0372303083210, 0372303083128, 0372303083111
Application # ANDA213346
SPL Set ID 56026679-4002-a6c6-e063-6294a90a7b55
Established class (EPC) Cholinergic Muscarinic Antagonist
Mechanism of action Cholinergic Muscarinic Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-07-01
Route ORAL
Dosage form TABLET, FILM COATED
Substance SOLIFENACIN SUCCINATE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 72303-0832-2 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 72303-0832-02. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Cholinergic Muscarinic Antagonist class.

Pharmacologic class Cholinergic Muscarinic Antagonist
Drug family (ATC) Drugs for urinary frequency and incontinence
How it works Cholinergic Muscarinic Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerHEC Pharm USA Inc.
Application holderSUNSHINE LAKE PHARMA CO LTD
FDA applicationANDA213346 (ANDA)
Labeler code72303
First marketedJul 2026
Product typeHuman Prescription Drug
Portfolio29 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📖 What it is MedlinePlus · NLM

Solifenacin is used to treat overactive bladder (a bladder condition that causes sudden urges to urinate that may be hard to control). Solifenacin is in a class of medications called antimuscarinics. It works by relaxing the bladder muscles.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It helps calm an overactive bladder. If you're rushing to the bathroom constantly, waking up at night to urinate, or sometimes not making it in time, solifenacin works by blocking...
  • What exactly is solifenacin supposed to do for me?
  • Dry mouth is the most common side effect, and it's more noticeable at higher doses. Sipping water throughout the day, chewing sugar-free gum, or using a saliva substitute can all h...
  • The dry mouth is really bothering me — is there anything I can do?
📖 Read our full Solifenacin guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color white
ShapeRound
ImprintC77
Size8 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII XHX3C3X673
    Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.

7 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 30 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
solifenacin succinate 10 mg 31722-0028-30 Camber 30 tablets $0.175 AB Availability likely —
Solifenacin Succinate 10 mg 72205-0021-30 Novadoz 30 tablets $0.175 AB Availability likely —
Solifenacin Succinate 10 mg 67877-0528-30 Ascend 30 tablets $0.175 AB Availability likely —
Solifenacin succinate 10 mg 00591-3796-19 Actavis 90 tablets $0.175 AB Availability likely —
Solifenacin Succinate 10 mg 60505-4703-03 Apotex 30 tablets $0.175 AB Availability likely —
solifenacin succinate 10 mg 27241-0038-03 Ajanta 30 tablets $0.217 — FDA listed —
VESIcare 10 mg 51248-0151-01 Astellas 30 tablets $12.310 — Discontinued —
Solifenacin Succinate 10 mg 29300-0329-05 Unichem 500 tablets — AB FDA listed —
Solifenacin Succinate 10 mg 46708-0193-08 Alembic 80 tablets — AB FDA listed —
Solifenacin Succinate 10 mg 50228-0428-05 ScieGen 500 tablets — AB FDA listed —
Solifenacin Succinate 10 mg 62332-0193-08 Alembic 80 tablets — AB FDA listed —
Solifenacin Succinate 10 mg 71205-0583-30 Proficient 30 tablets — AB FDA listed —
Solifenacin Succinate 10 mg 51407-0472-30 Golden 30 tablets — AB FDA listed —
Solifenacin Succinate 10 mg 72162-1849-03 Bryant 30 tablets — AB FDA listed —
solifenacin succinate 10 mg 33342-0149-07 Macleods 30 tablets — AB FDA listed —
Solifenacin Succinate 10 mg 35561-0286-10 Bostal 30 tablets — AB FDA listed —
Solifenacin Succinate 10 mg 42291-0740-30 AvKARE 30 tablets — AB FDA listed —
Solifenacin succinate 10 mg 82804-0058-30 Proficient 30 tablets — AB FDA listed —
Solifenacin Succinate 10 mg 63629-8870-01 Bryant 90 tablets — AB FDA listed —
Solifenacin Succinate 10 mg 82804-0266-30 Proficient 30 tablets — AB FDA listed —
Solifenacin Succinate 10 mg 63629-8869-01 Bryant 30 tablets — AB FDA listed —
Solifenacin Succinate 10 mg 65862-0879-03 Aurobindo 10 tablets — AB FDA listed —
Solifenacin Succinate 10 mg 71335-2985-01 Bryant 30 tablets — AB FDA listed —
Solifenacin succinate 10 mgthis 72303-0832-02 HEC 90 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2026
On the market since
Jul 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Solifenacin Succinate — the program that covers self-administered drugs. 11 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Solifenacin Succinate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$16.12M
Claims incl. refills
445.4K
Beneficiaries
302.9K
Spend / beneficiary
$53.24
Spend / claim
$36.20
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
72303-0832-01 30 TABLET, FILM COATED in 1 BOTTLE (72303-0832-1) 2026-07-01 Active
72303-0832-02 You're viewing this 90 TABLET, FILM COATED in 1 BOTTLE (72303-0832-2) 2026-07-01 Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 72303-0832-02?
NDC 72303-0832-02 is a 90-count package — 90 tablet, film coated in 1 bottle.
What is the difference between NDC 72303-0832-02 and NDC 72303-0832-01?
Both are Solifenacin succinate 10 mg Tablet, Film Coated — the drug itself is identical. NDC 72303-0832-02 is the 90-count package, while NDC 72303-0832-01 is the 30 tablets package.
What NDC number is used to bill for this package of Solifenacin succinate 10 mg Tablet, Film Coated?
Bill NDC 72303-0832-02 — the 11-digit billing format is 72303083202. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 72303-0832-2, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 72303-0832-02, written without dashes as 72303083202. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 72303-0832-02, the first segment (72303) is the labeler code FDA assigned to HEC Pharm USA Inc.; the middle segment (0832) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by HEC Pharm USA Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 30 tablets (72303-0832-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
HEC Pharm USA Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 54 words ▾

1 INDICATIONS AND USAGE Solifenacin succinate is indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Solifenacin succinate is a muscarinic antagonist indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. ( 1 )

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION 5 mg tablet taken orally once daily, and if well tolerated may be increased to 10 mg once daily. ( 2.1 ) Do not exceed the 5 mg dose of Solifenacin succinate tablets in patients with: Severe renal impairment creatinine clearance < 30 mL/min/1.73 m 2 . ( 2.2 , 8.6 ) Moderate hepatic impairment (Child-Pugh B).

Solifenacin succinate tablets are not recommended in patients with severe hepatic impairment (Child-Pugh C). ( 2.3 , 8.7 ) Concomitant use of strong CYP3A4 inhibitors. ( 2.4 , 7.1 )

2.1Dosing Information The recommended oral dose of solifenacin succinate tablets is 5 mg once daily. If the 5 mg dose is well tolerated, the dose may be increased to 10 mg once daily. Solifenacin succinate tablets should be taken with water and swallowed whole. Solifenacin succinate tablets can be administered with or without food.

2.2Dosing Recommendations in Patients with Renal Impairment Do not exceed 5 mg once daily in patients with severe renal impairment (CL cr < 30 mL/min/1.73 m 2 ) [see Use in Specific Populations ( 8.6 )] .

2.3Dosing Recommendations in Patients with Hepatic Impairment Do not exceed 5 mg once daily in patients with moderate hepatic impairment (Child-Pugh B). Do not use Solifenacin succinate tablets in patients with severe hepatic impairment (Child-Pugh C) [see Use in Specific Populations ( 8.7 )] .

2.4Dosing Recommendations in Patients Taking CYP3A4 Inhibitors Do not exceed 5 mg once daily when Solifenacin succinate tablets are administered with strong CYP3A4 inhibitors such as ketoconazole [see Drug Interactions ( 7.1 )] .

💊 Dosage Forms and Strengths 62 words ▾

3 DOSAGE FORMS AND STRENGTHS The 5 mg tablets are white or almost white round film-coated tablets, debossed with “C2” on one side and blank on the other side. The 10 mg tablets are white or almost white round film-coated tablets, debossed with “C77” on one side and blank on the other side. Tablets: 5 mg and 10 mg. ( 3 )

⛔ Contraindications 111 words ▾

4 CONTRAINDICATIONS Solifenacin succinate is contraindicated in patients: With urinary retention [see Warnings and Precautions ( 5.2 )] , With gastric retention [see Warnings and Precautions ( 5.3 )] , With uncontrolled narrow-angle glaucoma [see Warnings and Precautions ( 5.5 )] , and Who have demonstrated hypersensitivity to solifenacin succinate or the inactive ingredients in Solifenacin succinate tablets. Reported adverse reactions have included anaphylaxis and angioedema [see Adverse Reactions ( 6.2 )] . Urinary retention.

( 4 , 5.2 ) Gastric retention. ( 4 , 5.3 ) Uncontrolled narrow-angle glaucoma. ( 4 , 5.5 ) Hypersensitivity to this product or any of its components.

( 4 , 5.1 , 6.2 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Angioedema and Anaphylactic Reactions : Promptly discontinue Solifenacin succinate tablets and provide appropriate therapy. ( 5.1 ) Urinary Retention : Solifenacin succinate tablets are not recommended for use in patients with clinically significant bladder outlet obstruction. ( 5.2 ) Gastrointestinal Disorders : Solifenacin succinate tablets are not recommended for use in patients with decreased gastrointestinal motility.

( 5.3 ) Central Nervous System Effects : Somnolence has been reported with solifenacin succinate. Advise patients not to drive or operate heavy machinery until they know how solifenacin succinate affects them. ( 5.4 ) Controlled Narrow-Angle Glaucoma : Use Solifenacin succinate tablets with caution in patients being treated for narrow-angle glaucoma.

( 5.5 ) QT Prolongation in Patients at High Risk of QT Prolongation : Solifenacin succinate tablets are not recommended for use in patients at high risk of QT prolongation, including patients with a known history of QT prolongation and patients taking medications known to prolong the QT interval. ( 5.6 )

5.1Angioedema and Anaphylactic Reactions Angioedema of the face, lips, tongue, and/or larynx have been reported with solifenacin succinate. In some cases, angioedema occurred after the first dose, however, cases have been reported to occur hours after the first dose or after multiple doses. Anaphylactic reactions have also been reported in patients treated with solifenacin succinate.

Angioedema associated with upper airway swelling and anaphylactic reactions may be life-threatening. Solifenacin succinate tablets are contraindicated in patients with a known or suspected hypersensitivity to solifenacin succinate [see Contraindications ( 4 )] . If involvement of the tongue, hypopharynx, or larynx occurs, promptly discontinue Solifenacin succinate tablets and provide appropriate therapy and/or measures necessary to ensure a patent airway.

5.2Urinary Retention The use of Solifenacin succinate tablets, like other antimuscarinic drugs, in patients with clinically significant bladder outlet obstruction including patients with urinary retention, may result in further urinary retention and kidney injury. The use of Solifenacin succinate tablets is not recommended in patients with clinically significant bladder outlet obstruction and is contraindicated in patients with urinary retention [see Contraindications ( 4 )] .

5.3Gastrointestinal Disorders The use of Solifenacin succinate tablets, like other antimuscarinic drugs, in patients with conditions associated with decreased gastrointestinal motility may result in further decreased gastrointestinal motility. Solifenacin succinate tablets are contraindicated in patients with gastric retention [see Contraindications ( 4 )] . The use of Solifenacin succinate tablets is not recommended in patients with conditions associated with decreased gastrointestinal motility.

5.4Central Nervous System Effects Solifenacin succinate is associated with antimuscarinic central nervous system (CNS) adverse reactions [see Adverse Reactions ( 6.2 )] . A variety of CNS antimuscarinic adverse reactions have been reported, including headache, confusion, hallucinations, and somnolence. Monitor patients for signs of antimuscarinic CNS adverse reactions, particularly after beginning treatment or increasing the dose.

Advise patients not to drive or operate heavy machinery until they know how solifenacin succinate affects them. If a patient experiences antimuscarinic CNS adverse reactions, consider dose reduction or drug discontinuation.

5.5Controlled Narrow-Angle Glaucoma Solifenacin succinate should be used with caution in patients being treated for narrow-angle glaucoma [see Contraindications ( 4 )] .

5.6QT Prolongation in Patients at High Risk of QT Prolongation In a study of the effect of solifenacin succinate on the QT interval conducted in 76 healthy women [see Clinical Pharmacology ( 12.2 )] , solifenacin succinat…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The most common adverse reactions (> 4% in Solifenacin succinate tablets-treated patients and > placebo-treated patients) were dry mouth and constipation at both 5 mg and 10 mg doses; and urinary tract infection and blurred vision at the 10 mg dose. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact HEC Pharm USA Inc. at 1-800-610-5709 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Solifenacin succinate has been evaluated for safety in 1811 adult patients in four randomized, placebo-controlled trials (Studies 1-4) [see Clinical Studies ( 14 )] . Expected adverse reactions of antimuscarinic agents are dry mouth, constipation, blurred vision (accommodation abnormalities), urinary retention, and dry eyes.

The incidence of dry mouth and constipation in patients treated with solifenacin succinate tablets was higher in the 10 mg dose group compared to the 5 mg dose group. In the four 12-week double-blind clinical trials, severe fecal impaction, colonic obstruction, and intestinal obstruction were reported in one patient each, all in the solifenacin succinate 10 mg group. Angioneurotic edema was reported in one patient taking solifenacin succinate 5 mg.

Compared to 12 weeks of treatment with solifenacin succinate, the incidence and severity of adverse reactions were similar in patients who remained on drug for up to 12 months in Study 5 [see Clinical Studies ( 14 )] . The most frequent adverse reaction leading to study discontinuation was dry mouth (1.5%). Table 1 lists the rates of identified adverse reactions, in the four randomized, placebo-controlled trials at an incidence greater than placebo and in 1% or more of patients treated with solifenacin succinate 5 or 10 mg once daily for up to 12 weeks.

Table 1: Adverse Reactions Reported by ≥ 1% of Patients and Exceeding Placebo in Studies 1, 2, 3 and 4 Placebo (%) Solifenacin succinate tablets 5 mg (%) Solifenacin succinate tablets 10 mg (%) Number of Patients 1216 578 1233 GASTROINTESTINAL DISORDERS Dry Mouth 4.2 10.9

27.6Constipation 2.9 5.4

13.4Nausea 2.0 1.7

3.3Dyspepsia 1.0 1.4

3.9Abdominal Pain Upper 1.0 1.9

1.2Vomiting NOS 0.9 0.2

1.1INFECTIONS AND INFESTATIONS Urinary Tract Infection NOS >2.8 2.8

4.8Influenza 1.3 2.2

0.9Pharyngitis NOS 1.0 0.3

1.1NERVOUS SYSTEM DISORDERS Dizziness 1.8 1.9

1.8EYE DISORDERS Vision Blurred 1.8 3.8

4.8Dry Eyes NOS 0.6 0.3

1.6RENAL AND URINARY DISORDERS Urinary Retention 0.6 0

1.4GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Edema Lower Limb 0.7 0.3

1.1Fatigue 1.1 1.0

2.1PSYCHIATRIC DISORDERS Depression NOS >0.8 1.2

0.8RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS Cough 0.2 0.2

1.1VASCULAR DISORDERS Hypertension NOS 0.6 1.4 0.5

6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of solifenacin succinate in the U.S. and/or outside of the U.S. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. General disorders and administration site conditions : peripheral edema, hypersensitivity reactions (including angioedema with airway obstruction, rash, pruritus, urticaria, anaphylactic reaction); Nervous system disorders : dizziness, headache, confusion, hallucinations, delirium, somnolence; Cardiac disorders : QT prolongation, Torsade de Pointes, atrial fibrillation, tachycardia, palpitations; Hepatobiliary disorders : liver disorders mostly characterized by abnormal liver function tests, AST (aspartate aminotransferase), ALT (alanine aminotransferase), GGT (gamma-glutamyl transferase); Renal and urinary disorde…

🔄 Drug Interactions 88 words ▾

7 DRUG INTERACTIONS CYP3A4 Inhibitors : Do not exceed the 5 mg dose of Solifenacin succinate tablets with concomitant use of strong CYP3A4 inhibitors. ( 7.1 )

7.1Strong CYP3A4 Inhibitors Solifenacin is a substrate of CYP3A4. Concomitant use of ketoconazole, a strong CYP3A4 inhibitor, significantly increased the exposure of solifenacin [see Clinical Pharmacology ( 12.3 )] . The dosage of Solifenacin succinate tablets greater than 5 mg once daily is not recommended when concomitantly used with strong CYP3A4 inhibitors [see Dosage and Administration ( 2.4 )] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no studies with the use of solifenacin succinate in pregnant women to inform a drug-associated risk of major birth defects, miscarriages, or adverse maternal or fetal outcomes. No adverse developmental outcomes were observed in animal reproduction studies with oral administration of solifenacin succinate to pregnant mice during the period of organogenesis at a dose resulting in 1.2 times the systemic exposure at the maximum recommended human dose (MRHD) of 10 mg/day. However, administration of doses 3.6 times and greater than the MRHD during organogenesis produced maternal toxicity in the pregnant mice and resulted in developmental toxicity and reduced fetal body weights in offspring [see Data ] .

In the U.S. general population, the estimated background risk of major birth defects or miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Oral administration of 14 C-solifenacin succinate to pregnant mice resulted in the recovery of radiolabel in the fetus indicating that solifenacin-related product can cross the placental barrier. In pregnant mice, administration of solifenacin succinate at a dose of 250 mg/kg/day (7.9 times the systemic exposure at the MRHD of 10 mg), resulted in an increased incidence of cleft palate and increased maternal lethality.

Administration of solifenacin succinate to pregnant mice during organogenesis at greater than or equal to 3.6 times (100 mg/kg/day and greater) the systemic exposure at the MRHD, resulted in reduced fetal body weights and reduced maternal body weight gain. No embryo-fetal toxicity or teratogenicity was observed in fetuses from pregnant mice treated with solifenacin succinate at a dose of 30 mg/kg/day (1.2 times the systemic exposure at the MRHD). Administration of solifenacin succinate to pregnant rats and rabbits at a dose of 50 mg/kg/day (< 1 times and 1.8 times the systemic exposure at the MRHD, respectively), resulted in no findings of embryo-fetal toxicity.

Oral pre- and post-natal administration of solifenacin succinate at 100 mg/kg/day (3.6 times the systemic exposure at the MRHD) during the period of organogenesis through weaning, resulted in reduced peripartum and postnatal survival, reduced body weight gain by the pups, and delayed physical development (eye opening and vaginal patency). An increase in the percentage of male offspring was also observed in litters from offspring (F2 generation) exposed to maternal doses of 250 mg/kg/day. There were no effects on natural delivery in mice treated with 1.2 times (30 mg/kg/day) the expected systemic exposure at the MRHD.

8.2Lactation Risk Summary There is no information on the presence of solifenacin in human milk, the effects on the breastfed child, or the effects on milk production. Solifenacin is present in mouse milk [see Data ] . When a drug is present in animal milk, it is likely that the drug will be present in human milk.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Solifenacin succinate tablets and any potential adverse effects on the breastfed child from Solifenacin succinate tablets or from the underlying maternal condition. Data Animal Data Oral administration of 14 C-solifenacin succinate to lactating mice resulted in the recovery of radioactivity in maternal milk. Lactating female mice orally administered solifenacin succinate at a maternally toxic dose of 100 mg/kg/day (3.6 times the systemic exposure at the MRHD) had increased postpartum pup mortality, pups with reduced body weights, or delays in the onset of reflex and physical development.

Pups from lactating dams orally administered solifenacin succinate at a dose of 30 mg/kg/day (1.2 times the systemic exposure at the MRHD) had no discernible adverse findings. The concentrations of solifenacin in animal milk does not necessarily predict the concentration of drug in human mi…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary There are no studies with the use of solifenacin succinate in pregnant women to inform a drug-associated risk of major birth defects, miscarriages, or adverse maternal or fetal outcomes. No adverse developmental outcomes were observed in animal reproduction studies with oral administration of solifenacin succinate to pregnant mice during the period of organogenesis at a dose resulting in 1.2 times the systemic exposure at the maximum recommended human dose (MRHD) of 10 mg/day. However, administration of doses 3.6 times and greater than the MRHD during organogenesis produced maternal toxicity in the pregnant mice and resulted in developmental toxicity and reduced fetal body weights in offspring [see Data ] .

In the U.S. general population, the estimated background risk of major birth defects or miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Oral administration of 14 C-solifenacin succinate to pregnant mice resulted in the recovery of radiolabel in the fetus indicating that solifenacin-related product can cross the placental barrier. In pregnant mice, administration of solifenacin succinate at a dose of 250 mg/kg/day (7.9 times the systemic exposure at the MRHD of 10 mg), resulted in an increased incidence of cleft palate and increased maternal lethality.

Administration of solifenacin succinate to pregnant mice during organogenesis at greater than or equal to 3.6 times (100 mg/kg/day and greater) the systemic exposure at the MRHD, resulted in reduced fetal body weights and reduced maternal body weight gain. No embryo-fetal toxicity or teratogenicity was observed in fetuses from pregnant mice treated with solifenacin succinate at a dose of 30 mg/kg/day (1.2 times the systemic exposure at the MRHD). Administration of solifenacin succinate to pregnant rats and rabbits at a dose of 50 mg/kg/day (< 1 times and 1.8 times the systemic exposure at the MRHD, respectively), resulted in no findings of embryo-fetal toxicity.

Oral pre- and post-natal administration of solifenacin succinate at 100 mg/kg/day (3.6 times the systemic exposure at the MRHD) during the period of organogenesis through weaning, resulted in reduced peripartum and postnatal survival, reduced body weight gain by the pups, and delayed physical development (eye opening and vaginal patency). An increase in the percentage of male offspring was also observed in litters from offspring (F2 generation) exposed to maternal doses of 250 mg/kg/day. There were no effects on natural delivery in mice treated with 1.2 times (30 mg/kg/day) the expected systemic exposure at the MRHD.

🧒 Pediatric Use 18 words ▾

8.4Pediatric Use The safety and effectiveness of solifenacin succinate tablets have not been established in pediatric patients.

🧓 Geriatric Use 48 words ▾

8.5Geriatric Use In placebo-controlled clinical studies, similar safety and effectiveness were observed between geriatric patients (623 patients ≥ 65 years and 189 patients ≥ 75 years) and younger adult patients (1188 patients < 65 years) treated with Solifenacin succinate tablets [see Clinical Pharmacology ( 12.3 )] .

🆘 Overdosage 125 words ▾

10 OVERDOSAGE Overdosage with solifenacin succinate can potentially result in severe antimuscarinic effects and should be treated accordingly. The highest dose ingested in an accidental overdose of solifenacin succinate was 280 mg (28 times the maximum dosage) in a 5-hour period. This case was associated with mental status changes.

Some cases reported a decrease in the level of consciousness. Intolerable antimuscarinic adverse reactions (fixed and dilated pupils, blurred vision, failure of heel-to-toe exam, tremors, and dry skin) occurred on day 3 in normal volunteers taking 50 mg daily (5 times the maximum recommended therapeutic dose) and resolved within 7 days following discontinuation of drug. In the event of overdose with solifenacin succinate, treat with gastric lavage and appropriate supportive measures.

ECG monitoring is also recommended.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Solifenacin is a competitive muscarinic receptor antagonist. Muscarinic receptors play an important role in several major cholinergically mediated functions, including contractions of urinary bladder smooth muscle.

12.2Pharmacodynamics Cardiac Electrophysiology The effect of 10 mg and 30 mg solifenacin succinate (three times the maximum recommended dose) on the QT interval was evaluated at the time of peak plasma concentration of solifenacin in a multi-dose, randomized, double-blind, placebo and positive-controlled (moxifloxacin 400 mg) trial [see Warnings and Precautions( 5.6)]. After receiving placebo and moxifloxacin sequentially, subjects were randomized to one of two treatment groups. One group (n=51) completed 3 additional sequential periods of dosing with solifenacin succinate 10, 20, and 30 mg while the second group (n=25) in parallel completed a sequence of placebo and moxifloxacin.

Study subjects were female volunteers aged 19 to 79 years. The 30 mg dose of solifenacin succinate (three times the highest recommended dose) was chosen for use in this study because this dose results in a solifenacin exposure that covers those observed upon coadministration of 10 mg solifenacin succinate with strong CYP3A4 inhibitors (e.g., ketoconazole, 400 mg). Due to the sequential dose escalating nature of the study, baseline ECG measurements were separated from the final QT assessment (of the 30 mg dose level) by 33 days.

The median difference from baseline in heart rate associated with the 10 and 30 mg doses of solifenacin succinate compared to placebo was -2 and 0 beats/minute, respectively. Because a significant period effect on QTc was observed, the QTc effects were analyzed utilizing the parallel placebo control arm rather than the pre-specified intra-patient analysis. Representative results are shown in Table 2.

Table 2: QTc changes in msec (90% CI) from baseline at T max (relative to placebo) 1 Drug/Dose Fridericia method (using mean difference) Solifenacin succinate 10 mg 2 (-3, 6) Solifenacin succinate 30 mg 8 (4, 13) 1 - Results displayed are those derived from the parallel design portion of the study and represent the comparison of Group 1 to time-matched placebo effects in Group 2. Moxifloxacin was included as a positive control in this study and, given the length of the study, its effect on the QT interval was evaluated in 3 different sessions.

The placebo-subtracted mean changes (90% CI) in QTcF for moxifloxacin in the three sessions were 11 (7, 14), 12 (8, 17), and 16 (12, 21), respectively. The QT interval prolonging effect of the highest solifenacin succinate dose (three times the maximum therapeutic dose) studied was not as large as that of the positive control moxifloxacin at its recommended dose. However, the confidence intervals overlapped, and this study was not designed to draw direct statistical conclusions between the drugs or the dose levels.

12.3Pharmacokinetics Absorption After oral administration of solifenacin succinate in healthy volunteers, peak plasma concentrations (C max ) of solifenacin were reached within 3 to 8 hours after administration and, at steady-state, ranged from 32.3 to 62.9 ng/mL for the 5 and 10 mg solifenacin succinate tablets, respectively. The absolute bioavailability of solifenacin is approximately 90%, with plasma concentrations of solifenacin proportional to the dose administered. Effect of Food Solifenacin succinate may be administered without regard to meals.

A single 10 mg dose administration of solifenacin succinate with food increased C max and AUC of solifenacin by 4% and 3%, respectively. Distribution Solifenacin is approximately 98% ( in vivo ) bound to human plasma proteins, principally to α 1 -acid glycoprotein. Solifenacin is highly distributed to non-CNS tissues, having a mean steady-state volume of distribution of 600 L.

Elimination The elimination half-life (t 1/2 ) of solifenacin following chronic dosing is approx…

🧬 Mechanism of Action 30 words ▾

12.1Mechanism of Action Solifenacin is a competitive muscarinic receptor antagonist. Muscarinic receptors play an important role in several major cholinergically mediated functions, including contractions of urinary bladder smooth muscle.

📦 How Supplied / Storage and Handling 112 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Solifenacin succinate tablets are supplied as round, film-coated tablets, available in bottles as follows: Each 5 mg tablet is white or almost white and debossed with “C2” on one side and blank on the other side, and is available as follows: Bottle of 30 NDC 72303-0831-1 Bottle of 90 NDC 72303-0831-2 Each 10 mg tablet is white or almost white and debossed with “C77” on one side and blank on the other side, and is available as follows: Bottle of 30 NDC 72303-0832-1 Bottle of 90 NDC 72303-0832-2 Store at 20ºC to 25ºC (68ºF-77ºF) with excursions permitted from 15ºC to 30ºC (59°F-86ºF) [see USP Controlled Room Temperature].

📋 Description 140 words ▾

11 DESCRIPTION Solifenacin succinate is a muscarinic receptor antagonist. Chemically, solifenacin succinate is a butanedioic acid compound with (1 S )-(3 R )-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1 H )-iso-quinolinecarboxylate (1:1) having an empirical formula of C 23 H 26 N 2 O 2 •C 4 H 6 O 4 , and a molecular weight of 480.55. The structural formula of solifenacin succinate is: Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder.

It is freely soluble at room temperature in water, glacial acetic acid, dimethyl sulfoxide, and methanol. Each solifenacin succinate tablet contains 5 or 10 mg of solifenacin succinate and is for oral administration. In addition to the active ingredient solifenacin succinate, each solifenacin succinate tablet also contains the following inactive ingredients: hypromellose, lactose anhydrous, magnesium stearate, silicified microcrystalline cellulose, lactose monohydrate, titanium dioxide and triacetin. structure of Solifenacin succinate

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Angioedema and Anaphylactic Reactions Inform patients that angioedema and anaphylactic reactions have been reported in patients treated with Solifenacin succinate tablets. Angioedema and anaphylactic reactions may be life-threatening.

Advise patients to promptly discontinue Solifenacin succinate tablets therapy and seek immediate attention if they experience edema of the tongue or laryngopharynx, or difficulty breathing [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )] . Urinary Retention Inform patients that Solifenacin succinate tablets may cause urinary retention in patients with conditions associated with bladder outlet obstruction [see Warnings and Precautions ( 5.2 )] . Gastrointestinal Disorders Inform patients that Solifenacin succinate tablets may cause further decrease in gastrointestinal motility in patients with conditions associated with decreased gastrointestinal motility.

Solifenacin succinate tablets have been associated with constipation and dry mouth. Advise patients to contact their health care providers if they experience severe abdominal pain or become constipated for 3 or more days [see Warnings and Precautions ( 5.3 )] . Central Nervous System Effects Because Solifenacin succinate tablets, like other antimuscarinic agents, may cause central nervous system effects or blurred vision, advise patients to exercise caution in decisions to engage in potentially dangerous activities until the drug’s effect on the patient has been determined [see Warnings and Precautions ( 5.4 )] .

Narrow-Angle Glaucoma Inform patients that Solifenacin succinate tablets, like other antimuscarinics, may cause worsening of the glaucoma condition in patients with narrow-angle glaucoma [see Warnings and Precautions ( 5.5 )] . Dry Skin Inform patients that Solifenacin succinate tablets, like other antimuscarinics, may cause dry skin due to decreased sweating. Heat prostration due to decreased sweating can occur when Solifenacin succinate tablets are used in a hot environment [see Adverse Reactions ( 6.2 )] .

Trademarks are the property of their respective owners. Manufactured by: Sunshine Lake Pharma Co., Ltd. No.

1, Northern Industry Road, Northern Industry Park of Song Shan Lake, Dongguan, Guangdong 523808, China Distributed by: HEC Pharm USA Inc. Plainsboro, NJ 08536 Revised: 07/2026 logo 1 logo 2

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 72303-0831-01 · HEC 72303-0835-01 · HEC →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.